In a first, FDA on Tuesday ordered a Las Vegas-based company to recall its powdered kratom products as part of the agency's response to a nationwide salmonella outbreak.
Kratom is derived from a tree native to Southeast Asia. In the United States, the substance has become a popular alternative treatment for individuals with chronic pain, as well as those trying to stop using alcohol or opioid drugs. Kratom's active ingredients include a chemical that binds to some of the same receptors in the body as opioids, which in turn can provide pain relief and a type of high.
Kratom is also available in the United States as a dietary supplement, and the American Kratom Association estimates that between three million and five million U.S. residents have used or are using kratom. FDA in recent months has been cracking down on the substance, which the agency says has no approved medical use and was associated with 44 deaths between April 2011 and December 2017.
Separately, kratom has been linked to a recent salmonella outbreak. CDC data show 87 people in 35 states have been diagnosed with salmonella infections linked to kratom as of March 15. CDC said no deaths have been reported, but 27 people were hospitalized. In response to the outbreak, FDA has been contacting companies that sell kratom products to issue voluntary product recalls.
FDA issues first mandatory recall
FDA said it ordered Las Vegas-based Triangle Pharmanaturals to remove its products from the market after the company ignored the agency's repeated requests to begin a voluntary recall.
FDA said samples of Triangle's kratom products tested by state and federal authorities came back positive for salmonella, but it noted that the strains the samples tested positive for were not the same as those linked to the ongoing salmonella outbreak.
The mandatory recall includes Triangle's Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, and Raw Form Organics Maeng Da Kratom Ruby Red, the Washington Post reports.
FDA Commissioner Scott Gottlieb said, "This action is based on the imminent health risk posed by the contamination of this product with salmonella, and the refusal of this company to voluntarily act to protect its customers and issue a recall." He added, "This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products."
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